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June 2016 Blog Posts (6)

A broad look at clinical research regulations

Clinical research regulations are directives that are aimed at making clinical research more effective and ethically justifiable. The tool or mechanism by which regulators ensure that clinical research regulations serve their purpose is what is called Good Clinical Practice (GCP).

Regulatory bodies around the world, irrespective of whether they function at national or global levels, formulate respective clinical research regulations that are aimed at ensuring that…

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Added by Adam Fleaming on June 10, 2016 at 3:16am — No Comments

What are the functions of computer system validation process?

Computer system validation process is described as the documented procedure which assures that a computer system performs the exact functions it is intended to reproducibly, consistently and verifiably. The computer system validation process covers every function and milestone of the computer system:

  • Development of the system
  • Operation of the system
  • The system’s maintenance
  • Its retirement
  • Archiving…
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Added by Adam Fleaming on June 7, 2016 at 2:24am — No Comments

Effective Steps for Validation and 21 CFR Part 11 Compliance (CSV)

If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.

In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:

  • The US FDA
  • European Medicines Agency (EMA)
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • Good Clinical Practices…
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Added by John Robinson on June 6, 2016 at 2:30am — No Comments

The emerging discipline of Hospitals Management Performance Assessments

The emerging discipline of Hospitals Management Performance Assessments

Over the past few years, Hospitals Management Performance Assessments have begun to gain acceptability and credence in healthcare circles. Hospitals Management Performance Assessments came into being as a result of a conscious effort by advanced countries, mainly European, with sufficient backing from the World Health Organization (WHO) to arrive at some sort of metrics…

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Added by Roger Steven on June 2, 2016 at 7:10am — No Comments

Implementation requirements of FDA's Bioresearch Monitoring Program

If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an FDA inspection is not going to invite an FDA action such as a 483…

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Added by Adam Fleaming on June 2, 2016 at 3:08am — No Comments

It is important to ensure food safety in hospitals

It is important to ensure food safety in hospitals

Food-Services

Hospitals being what they are – where patients of almost all kinds visit or stay – are very potent sources of infection. Infection can arise from any part of the hospital. They can spread from patients to patients, from caregivers to patients, from patients to caregivers, from patients to support or administrative staff and vice versa, and so on. An often overlooked source of infection and contamination…

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Added by Roger Steven on June 1, 2016 at 7:16am — No Comments

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Profile IconMOHAMMAD RAHMAN, Siva, Tim Sheehan and 5 more joined Online Safety Community
2 hours ago
kate smith posted a blog post

Understanding the Importance of Drafting the Employee Handbook Rightly

Employee handbooks are a great way for organizations to state their policies vis-à-vis employee behavior. On the one hand, they are a simple and reliable guide to letting employees and other people connected to the organization in one or another way about many aspects of the organization’s culture. On the other, employee…See More
7 hours ago
John Robinson posted a blog post

Implementing ICH guidelines-compliant validation

Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as:Analytical methods validationProcedures and acceptance criteria in calibration limits…See More
8 hours ago
Adam Fleaming posted a blog post

How to Comply and how to Protect Privacy

The General Data Protection Regulation (GDPR) –codified as Regulation (EU) 2016/679 – is an important law concerning the protection of data of all people living in the European Union (EU). Through the GDPR regulation; all the legislative and secretarial bodies of the EU, namely the European Parliament, the Council of the European Union and the European Commission, fortify and toughen and unify all aspects of…See More
9 hours ago

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What is Class Structure in Pega?

Class contains the rule by way of which objects behave. outline rules such as houses, sports, flows, html paperwork, etc. to be had to different subordinate classes. lessons are organized into a…Continue

Started by Soujanya Naganuri Jul 17.

How to Concatenate Two Tables in QlikView

Table combining and concatenationConcatenate appends the rows of one table to another. Concatenate never merges any rows. The number of rows in a concatenated table is always the sum of the rows of…Continue

Tags: datafields, developers, qlikview

Started by Soujanya Naganuri Jun 30.

SQL Server Windows Management Instrumentation Tasks

Hello,SSIS includes two special tasks that enable you to query system information and monitor system events: the WMI Data Reader Task and the WMI Event Watcher Task. These tasks are especially useful…Continue

Tags: Task, WMI, Server, SQL

Started by Madison Quinn Jun 20.

difference between NEBOSH and IOSH

NEBOSH “National Examination Board in Occupational Health and Safety”IOSH “Institution…Continue

Tags: kerala, IGC, NEBOSH

Started by mani May 31.

What's your favorite motivational/safety quote? 98 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by David R Snell Apr 26.

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